Search

Background: The quality of treatment is especially critical in the context of complex and chronic diseases such as multiple sclerosis (MS). The Brain Health Initiative, an independent international consortium of neurologists, reached a consensus on time-based quality standards prioritizing brain health-focused care for people with MS., Objectives: To gain deeper insights into the transferability of these quality standards to a specific area, we conducted a survey among MS experts across various MS centers in Germany., Methods: Participants were asked about time frames considered high standards and those currently being implemented in daily routine based on their experience., Results: The results reveal a large gap between ideal conceptions and their adaptation in the real world, mostly due to a lack of resources., Conclusions: Nevertheless, these guidelines and recommendations can be aspired to as ideals. Consensual and inclusive clinical pathways complemented by measurable quality indicators are needed to improve care and approach these ideals. Neither exists in the current management of MS., Competing Interests: Declarations Ethics approval and consent to participate Not applicable. Consent for publication Not applicable. Competing interests IV declares that she has no competing interests.KA received personal compensation from Roche, Sanofi, Novartis, Merck, Teva, and BMS for consulting or speaker service.HI received speaker honoraria from Roche and financial support for research activities from Teva, Biogen and Alexion.JH declares that the research was conducted in the absence of any commercial or financial relationships that could be construed as potential conflicts of interest.HT has no personal pecuniary interests to discluse, other than being the Secretary General of the German Multiple Sclerosis Society, Federal Association (DMSG), which recently received funding from a range of public and corporate sponsors, including G-BA, The German MS Trust, Biogen, Bristol Myers Squibb, Hexal, Merck, Novartis, Ottobock, Roche, Sanofi and Viatris.SGM declares that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.GG reports: In the last two years, GG has received compensation for serving as a consultant or speaker for or has received research support from Aurinia Pharmaceuticals, Biogen, BMS-Celgene, GlaxoSmithKline, Janssens/J&J, Japanese Tobacco, Merck KGaA/EMD Serono, Moderna, Novartis, Sandoz, Sanofi and Roche/Genentech.TZ reports the following: a scientific advisory board and/or consulting for Biogen, Roche, Novartis, Celgene, and Merck; compensation for serving on speakers bureaus for Roche, Novartis, Merck, Sanofi, Celgene, and Biogen; and research support from Biogen, Novartis, Merck, and Sanofi., (© 2024. The Author(s).)

Several studies reported post-SARS-CoV-2-vaccination (PV) symptoms. Even people with multiple sclerosis (PwMS) have concerns about disease activity following the SARS-CoV-2 vaccination. We aimed to determine the proportion of PwMS with PV relapses, the PV annualized relapse rate (ARR), the time from vaccination to subsequent relapses, and identify sociodemographic/clinical risk factors for PV relapses. PwMS were surveyed several times at baseline and four follow-ups as part of a longitudinal observational study regarding the safety and tolerability of the SARS-CoV-2 vaccination. The inclusion criteria for this analysis were age ≥18 years, ≥1 SARS-CoV-2 vaccination, and ≥1-year observation period since initial vaccination. Of 2466 PwMS, 13.8% reported PV relapses (mostly after second [N = 147] or booster vaccination [N = 145]) at a median of 8.0 (first/third quantile: 3.55/18.1) weeks PV, with the shortest period following initial vaccination (3.95 weeks). The ARR was 0.153 (95% confidence interval: 0.138-0.168), with a median observation period since initial vaccination of 1.2 years. Risk factors for PV relapses were younger age, female gender, moderate-severe disability levels, concurrent autoimmune diseases, relapsing-remitting MS courses, no DMT, and relapses within the year prior to the first vaccination. Patients' health conditions before/during initial vaccination may play a more important role in PV relapse occurrence than vaccination per se.

Background: Receiving a multiple sclerosis (MS) diagnosis is a significant stressor. Therefore, highly individualised counselling is needed, especially in early MS. Modifiable risk factors (e.g. smoking and obesity) are gaining relevance in MS. Despite evidence for worse MS-related health outcomes, prevalence of adverse health behaviours, such as smoking and physical inactivity, is high across all MS stages. However, knowledge regarding health behaviours as well as their association with MS-related health outcomes among newly diagnosed PwMS in Germany is scarce. Currently, the efficacy of an interactive digital lifestyle management application intended to be used as an add-on to standard care among newly diagnosed PwMS in Germany is evaluated in an ongoing multicentre randomised controlled trial (RCT) ('POWER@MS1')., Objectives: To describe baseline disease characteristics and health behaviours of the POWER@MS1 cohort and investigate associations between MS characteristics, quality of life (QOL), health behaviours and intention to optimise health behaviour habits., Methods: This study included 234 persons with early MS from 20 study centres located across Germany who participate in the POWER@MS1 RCT. Participants were recruited by treating neurologists from different regions and health-care settings in Germany. Baseline data was obtained using paper-based questionnaires and a web-based healthy diet screener between July 2019 and end of March 2022 and analysed descriptively., Results: In this early MS cohort (mean disease duration 4 months), a screening tool showed severe symptoms of anxiety in 15 % of the participants. Better means for stress management appeared to be particularly relevant for the whole cohort. Moreover, 19 % were current smokers, 15 % were obese and 36 % were insufficiently physically active. On average, participants only moderately adhered to dietary guidelines for recommended intake of key food groups (e.g. vegetables, fruits and fatty marine fish). Higher EDSS scores were associated with approximately 20 % higher T2-lesion burden (rate ratio RR=1.2, p<0.001) and 13 % higher relapse rate (RR=1.13,p=0.02) per EDSS disability level. Moreover, a higher T2-lesion burden was associated with current smoking (RR=0.76, p=0.033), resulting in approximately 24 % less T2-lesions at disease onset among non-smokers. In addition, smoking was associated with unhealthier dietary habits according to lower diet scores (linear regression coefficient β=-1.27, p<0.001). Higher EDSS scores (β=0.19,p<0.001) and higher BMI (β=0.013,p=0.03) were associated with higher HAQUAMS (lower QOL). Further, lower diet scores (β=-0.044,p=0.039) were associated with lower QOL. Moreover, higher HAQUAMS (lower QOL) indicated a higher intention to optimise stress management (β=0.98,p<0.001), physical activity (β=0.74,p=0.046) and sleep behaviour (β=1.82,p<0.001). Further, higher intention to optimise stress management was accounted for by higher EDSS scores (β=0.39,p=0.004) and a higher number of T2-lesions (β=0.029,p=0.015) in this newly diagnosed MS cohort., Conclusion: Results indicate a clear need for modifications of health behaviours among newly diagnosed PwMS participating in POWER@MS1. Individualised psychological and health behaviour counselling appears to be an important factor in treatment, also for similar early MS cohorts and particularly in those who demonstrate a more severe disease in clinical and MRI metrics., Competing Interests: Declaration of Competing Interest CH has received research grants, speaker honoraria and travel grants from Biogen, Celgene, Genzyme, Merck and Roche; all outside of this work. HT has no personal pecuniary interests to disclose, other than being the Secretary General of the German MS Society, federal association, which receives funding from a range of public and corporate sponsors, recently including Bundesgesundheitsministerium (BMG), The German Innovation Fund (G-BA), The German MS Trust, Biogen, Bristol Myers Squibb, Merck Serono, Novartis, Roche, Sanofi, Viatris (former Mylan); none resulted in a conflict of interest. TF reports personnel fees from Bayer, BiosenseWebster, Boehringer Ingelheim, CSL Behring, Daiichi Sankyo, Enanta, Fresenius Kabi, Galapagos, Immunic, Janssen, LivaNova, Novartis, Relaxera, Roche, and Vifor; all outside this work. DB has received speaker honoraria and travel grants from Bayer, Novartis, Roche, Genzyme; all outside this work. AB has received consulting and/or speaker fees from Alexion, Biogen, Celgene, Horizon, Novartis, Roche and Sandoz/Hexal and his institution has received compensation for clinical trials from Alexion, Biogen, Merck, Novartis, Roche, and Sanofi Genzyme; all outside this work. KG has received compensation as investigator, advisor and speaker as well as travel fees from Abbvie, Almirall, Aristo, Bayer, Biogen, BMS, Celgene, Genzyme, Ipsen, Janssen, Merck, Novartis and Roche; all outside this work. SM has received financial support for consulting activities from Roche; all outside this work. PO received research support as well as speaking fees and travel fees from Alexion, Bayer Health Care, Biogen, Janssen, Merck Serono, Novartis, Pfizer, Roche, Sanofi Genzyme, TEVA; all outside this work. HR has received speaker honoraria from Roche, MerckSerono, and Novartis and participated in advisory boards for Novartis, Teva, and Hexal; all outside this work. SSch has received research grants, speaker honoraria and travel compensations from BayerVital, Biogen, Genzyme, Merck, Novartis, Roche, Teva; all outside this work. AS received speaker honoraria from Bayer and Biogen, and participated in AdBoards for Merck Serono; all outside this work. KHS has received speaker honoraria or travel grants from Biogen, Bristol Myers Squibb, Merck and Roche; all outside this work. CW has received institutional honoraria and/or grant support from Novartis, Sanofi-Genzyme, Alexion, Janssen, Merck, Biogen, and Roche; all outside this work. All other authors have nothing to declare., (Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.)

Despite protection from severe COVID-19 courses through vaccinations, some people with multiple sclerosis (PwMS) are vaccination-hesitant due to fear of post-vaccination side effects/increased disease activity. The aim was to reveal the frequency and predictors of post-SARS-CoV-2-vaccination relapses in PwMS. This prospective, observational study was conducted as a longitudinal Germany-wide online survey (baseline survey and two follow-ups). Inclusion criteria were age ≥18 years, MS diagnosis, and ≥1 SARS-CoV-2 vaccination. Patient-reported data included socio-demographics, MS-related data, and post-vaccination phenomena. Annualized relapse rates (ARRs) of the study cohort and reference cohorts from the German MS Registry were compared pre- and post-vaccination. Post-vaccination relapses were reported by 9.3% PwMS (247/2661). The study cohort's post-vaccination ARR was 0.189 (95% CI: 0.167-0.213). The ARR of a matched unvaccinated reference group from 2020 was 0.147 (0.129-0.167). Another reference cohort of vaccinated PwMS showed no indication of increased post-vaccination relapse activity (0.116; 0.088-0.151) compared to pre-vaccination (0.109; 0.084-0.138). Predictors of post-vaccination relapses (study cohort) were missing immunotherapy (OR = 2.09; 1.55-2.79; p < 0.001) and shorter time from the last pre-vaccination relapse to the first vaccination (OR = 0.87; 0.83-0.91; p < 0.001). Data on disease activity of the study cohort in the temporal context are expected for the third follow-up.

Background: A multiple sclerosis (MS) diagnosis urges decision-making on immunotherapies, while persons with MS (PwMS) need to develop a coping concept in parallel. At this stage, PwMS ask how they themselves may contribute to controlling the disease. Evidence suggests that maintaining a healthy lifestyle (e.g. physical activity and stress management) is a key factor for healthy aging and preserving activity, while data on MS are complex., Objectives: Following the Medical Research Council framework, this study aimed to develop and investigate the feasibility of a new digital health application that conveys evidence-based patient information about lifestyle factors in MS and engages PwMS in relevant behaviour change techniques., Methods: Based on a digital health application promoting lifestyle management in breast cancer survivors, an MS-specific adaptation ('levidex') was developed. Feasibility was tested with 15 PwMS and eight MS experts. Subsequently, a six-week pilot study with eight PwMS was conducted. All participants provided feedback on practicability and acceptability via a questionnaire and took part in a semi-structured telephone interview. Levidex was revised after each test phase., Results: The final levidex tool includes 16 modules, 177 references and several other functions. Feasibility results showed that PwMS and MS experts perceived levidex as understandable (14 out of 15; 6 out of 8), trustworthy (15 out of 15; 8 out of 8), and relevant (10 out of 15; 8 out of 8). Interviews revealed potential for improvement regarding the length and complexity of some content. Piloting of the revised version confirmed good feasibility and high acceptance. Most participants felt inspired to initiate (7 out of 8) or had already implemented (5 out of 8) lifestyle changes after working with levidex., Conclusion: Results suggest that levidex is feasible and well-accepted by PwMS and MS experts. It might be a useful tool to support PwMS in adapting to their diagnosis and initiating health-promoting lifestyle changes., Competing Interests: Competing interests: The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: CH has received research grants, speaker honoraria, and travel grants from Biogen, Celgene, Genzyme, Merck, and Roche. JP has received research grants, speaker honoraria, and travel grants from Bayer, Celgene, and Merck. BM and FT are employed by GAIA, the company that developed, owns, and operates levidex. NK, KR-L, ACR, SK, HT, and MvdL have nothing to declare., (© The Author(s), 2022.)

Background: Vaccines offer people with multiple sclerosis (PwMS) an effective protection against severe COVID-19 disease courses. However, representative real-world data on the tolerability of SARS-CoV-2 vaccines in PwMS are limited. We aimed at analysing vaccination reactions (VRs) and MS deterioration following SARS-CoV-2 vaccinations in German and United Kingdom (UK) PwMS, especially regarding gender-specific differences., Methods: The German Multiple Sclerosis Society and the UK MS Registry acquired health data via an online system following the first (X 1 ) and second SARS-CoV-2 vaccination (X 2 ), respectively: sociodemographic and clinical data, vaccines used, VRs, MS deterioration (worsened or new MS symptoms, Germany only) and relapses (Germany only). The frequencies of VRs and MS deterioration were analysed stratified by gender., Findings: Following X 1 (X 2 ), 2346 (1835) German PwMS and 3796 (683) UK PwMS participated in the study. The most frequent vaccination scheme was two-dose tozinameran for Germany (77·1%, 1424/1847) and two-dose AZD1222 for the UK (61·3%, 419/683). The most common VRs were fatigue, headache and pain (at the injection site) and occurred more often in women compared with men. German PwMS reported VRs more frequently after X 2 vs. X 1 (65·4% [1201/1835] vs. 61·2% [1435/2346]), while for UK patients it was the opposite (X 1 vs. X 2 : 48·7% [1849/3796] vs. 30·0% [205/683]). MS deterioration occurred in 19·0% (445/2346) of the German PwMS without resulting in gender-specific differences. Fatigue and gait impairment were the most frequent deteriorated MS symptoms., Interpretation: Female PwMS reported experiencing VRs more often than men. Longitudinal data are needed to enable valid statements regarding long-term MS deterioration and long-lasting VRs., Funding: German Multiple Sclerosis Society (DMSG Bundesverband e.V.), Biogen, Bristol Myers Squibb, Merck Serono, Mylan, Novartis, Roche and Sanofi., Competing Interests: Niklas Frahm is an employee of the MSFP. Moreover, he is an employee of Rostock's University Medical Center and received travel funds for research meetings from Novartis; none resulted in a conflict of interest. Firas Fneish, Melanie Peters, David Ellenberger and Sarah Schilling had no personal financial interests to disclose other than being employees of the German MS Registry; none resulted in a conflict of interest. Tina Parciak had no personal financial interests to disclose. Anna-Lena Röper is employee of the MSFP and Germany MS society, which is funded by many public and corporate sponsors. She received travel funds from Novartis. None resulted in a conflict of interest. Micha Löbermann received speaker honoraria from Sanofi, AbbVie and Pfizer, he served as investigator in vaccine studies sponsored by Janssen, GSK and Novartis; none resulted in a conflict of interest. Herbert Temmes has no personal pecuniary interests to disclose, other than being the Secretary General of the German MS Society, federal association, which receives funding from a range of public and corporate sponsors, recently including Bundesgesundheitsministerium (BMG), The German Innovation Fund (G-BA), The German MS Trust, Biogen, Bristol Myers Squibb, Merck Serono, Novartis, Roche, Sanofi, Viatris (former Mylan); none resulted in a conflict of interest. Judith Haas has no personal pecuniary interests to disclose, other than being the President of the German MS Society, federal association, which receives funding from a range of public and corporate sponsors, recently including BMG, G-BA, The German MS Trust, Biogen, Bristol Myers Squibb, Merck Serono, Novartis, Roche, Sanofi, Viatris (former Mylan); none resulted in a conflict of interest. Dieter Pöhlau received speaking fees, travel support and financial support for research projects from: Allmirall, Bayer, Biogen-Idec, Merck-Serono, Octapharm, Novartis, Roche, Sanofi-Aventis and Teva; none resulted in a conflict of interest. Jeff Rodgers has no personal pecuniary interests to disclose, other than being an employee of the UK MS Register which is funded by the MS Society, travel research and conference costs are also funded by them; none resulted in a conflict of interest. Uwe K. Zettl has received speaking fees, travel support and /or financial support for research activities from Alexion, Almirall, Bayer, Biogen, Bristol-Myers-Squibb, Janssen, Merck Serono, Novartis, Octapharm, Roche, Sanofi Genzyme, Teva as well as EU, BMBF, BMWi and DFG; none resulted in a conflict of interest. Alexander Stahmann has no personal financial interests to disclose, other than being the leader of the German MS Registry, which receives funding from a range of public and corporate sponsors, recently including G-BA, The German MS Trust, German MS Society, Biogen, Bristol Myers Squibb, Merck, Novartis, Roche and Sanofi; none resulted in a conflict of interest. Rod Middleton has no personal pecuniary interests to disclose, other than being the lead of the UK MS Register which is funded by the MS Society, travel research and conference costs are also funded by them; none resulted in a conflict of interest., (© 2022 MS Forschungs- und Projektentwicklungs-gGmbH (MS Research and Project Development gGmbH).)

Introduction: Patients with multiple sclerosis (MS) have complex needs that range from organising one's everyday life to measures of disease-specific therapy monitoring to palliative care. Patients with MS are likely to depend on multiple healthcare providers and various authorities, which are often difficult to coordinate. Thus, they will probably benefit from comprehensive cross-sectoral coordination of services provided by care and case management (CCM). Though studies have shown that case management improves quality of life (QoL), functional status and reduces service use, such benefits have not yet been investigated in severely affected patients with MS. In this explorative phase ll clinical trial, we evaluated a CCM with long-term, cross-sectoral and outreaching services and, in addition, considered the unit of care (patients and caregivers)., Methods and Analysis: Eighty patients with MS and their caregivers will be randomly assigned to either the control (standard care) or the intervention group (standard care plus CCM (for 12 months)). Regular data assessments will be done at baseline and then at 3-month intervals. As primary outcome, we will evaluate patients' QoL. Secondary outcomes are patients' treatment-related risk perception, palliative care needs, anxiety/depression, use of healthcare services, caregivers' burden and QoL, meeting patients' and caregivers' needs, and evaluating the CCM intervention. We will also evaluate CCM through individual interviews and focus groups. The sample size calculation is based on a standardised effect of 0.5, and one baseline and four follow-up assessments (with correlation 0.5). Linear mixed models for repeated measures will be applied to analyse changes in quantitative outcomes over time. Multiple imputation approaches are taken to assess the robustness of the results. The explorative approach (phase ll clinical trial) with embedded qualitative research will allow for the development of a final design for a confirmative phase lll trial., Ethics and Dissemination: The trial will be conducted under the Declaration of Helsinki and has been approved by the Ethics Commission of Cologne University's Faculty of Medicine. Trial results will be published in an open-access scientific journal and presented at conferences., Trial Registration Number: German Register for Clinical Studies (DRKS) (DRKS00022771)., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Multiple sclerosis (MS) is an inflammatory and degenerative disease of the central nervous system that mainly affects young adults. Uncertainty is a major psychological burden of the disease from diagnosis to prognosis, enhanced by the pressure to make early decisions on a diverse set of immunotherapies. Watchful waiting for 1-2 years while adapting goals and lifestyle habits to life with a chronic disease represents another reasonable option for persons with MS (PwMS). A behaviour change programme based on evidence-based patient information (EBPI) is not available in standard care. This randomised controlled trial (RCT) with an embedded process evaluation investigates the efficacy and cost-effectiveness of a web-based behavioural lifestyle programme to change lifestyle behaviour and reduce inflammatory disease activity in PwMS., Methods and Analysis: A web-based behavioural intervention will be evaluated in an RCT aiming to recruit 328 persons with clinically isolated syndrome, suspected MS or confirmed MS for less than 1 year, who have not yet started immunotherapy. Moreover, a mixed-methods process evaluation and a health economic evaluation will be carried out. Participants will be recruited in at least 16 MS centres across Germany and randomised to an intervention group with 12 months of access to EBPI about lifestyle factors in MS, combined with a complex behaviour change programme or to a control group (optimised standard care). The combined primary endpoint is the incidence of new T2 lesions on MRI or confirmed relapses., Ethics and Dissemination: The study has been approved by the Ethics Committee of the Hamburg Chamber of Physicians (PV6015). Trial results will be communicated at scientific conferences and meetings and presented on relevant patient websites and in patient education seminars., Trial Registration Number: ClinicalTrials.gov Registry (NCT03968172); Pre-results., Competing Interests: Competing interests: CH has received research grants, speaker honoraria and travel grants from Biogen, Celgene, Genzyme, Merck, Roche. J-PS receives research funding from Deutsche Forschungsgemeinschaft and reports grants from Biogen and Genzyme outside the submitted work. TF reports personnel fees from Bayer, BiosenseWebster, Boehringer Ingelheim, CSL Behring, Daiichi Sankyo, Enanta, Fresenius Kabi, Galapagos, Immunic, Janssen, LivaNova, Novartis, Relaxera, Roche, and Vifor; all outside this work., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)